Short Antibiotic Treatment Versus Duration Guided by Markers of Inflammation in the Treatment of AECOPD

• Status: Completed
• Trial end date: 2019-01-31
• Target enrollment: 0
• Participant gender: All

Summary

Chronic obstructive pulmonary disease (COPD) is one of the most common diseases in the world. In a recent study, we showed that administration of levofloxacin is superior to placebo in the treatment of decompensation of COPD; it is accompanied by a substantial reduction in mortality and a significant reduction in the residence time in hospital.

In Tunisia, few data are available on the epidemiology of COPD decompensation. The choice of antibiotic to be used in this situation is challenging to the clinician who must choose between traditional antibiotics (cyclins, aminopenicillins, cotrimoxazole...) and new antimicrobial agents. Recently, it has been emphasized the selection of patients for treatment according to the degree of systemic inflammation (C-Reactive Protein). Indeed, there would have a correlation between the tracheobronchial infection and elevated inflammatory markers. As the elevation of these markers is proportional to the intensity of the inflammatory reaction of the body, is based on the kinetics of these biomarkers in antibiotic treatment seems logical. Thus, C-Reactive Protein allowed not only knowing when to start antibiotics, but also through their kinetic, these markers can guide the duration of therapy and shorten the duration of antibiotic therapy: a rate cut would ensure that the antibiotic treatment was adopted. Available guidelines stated that antibiotic treatment should be maintained at an average of 7 to 10 days while some studies showed no clinical inferiority of courses as short as 3 days. Further reduction of the duration of antibiotherapy was even suggested in order to reduce the risk of adverse events and the pressure that drives bacterial resistance. Hence, we conducted this study using an algorithm to comprehensively evaluate the role of CRP-guided antibiotic prescription in optimizing treatment duration in AECOPD.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Monastir
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Levofloxacin; Ofloxacin

Criteria

Inclusion Criteria:

• patients having COPD (according to the definition of the American Thoracic Society) in acute exacerbation

Exclusion Criteria:

• clinical evidence of hemodynamic compromise with the need for vasoactive drugs

• immediate need for mechanical ventilation,

• Glasgow Coma scale <12,

• pneumonia,

• previous adverse reactions to the study drug,

• antibiotic treatment in the previous days,

• pregnancy or lactation,

• severe renal (creatinine clearance 40 mL/min) or hepatic impairment,

• lung disease other than COPD that could affect the clinical evaluation of the treatments. --active alcohol or drug abuse